Gilead Single-Tab HIV Regimen Approved for New Group

Gilead Sciences has received approval from the FDA for the single tablet HIV-1 regimen Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed adult patients on a stable antiretroviral regimen in order to replace their current antiretroviral treatment regimen. Complera was first approved in 2011 for patients new to therapy and is now one of the most widely-prescribed HIV regimens in the U.S.

Complera combines a complete course of three antiretroviral medications into a single, once-daily tablet. The product contains Gilead’s Truvada, which itself is a fixed-dose combination of two HIV medicines, and Janssen R&D Ireland’s rilpivirine (marketed as Edurant). Patients switching to Complera should have no history of virologic failure, have suppressed viral load for at least six months, be on their first or second antiretroviral regimen, and have no current or past history of resistance to Complera components. The efficacy of Complera was established in patients who were virologically suppressed on a stable ritonavir-boosted protease inhibitor-containing regimen.

This approval is supported by clinical data from the Phase III SPIRIT clinical trial. In this randomized, open-label study, virologically suppressed patients who were taking multi-tablet HIV therapy containing a ritonavir-boosted protease inhibitor (PI) either switched to Complera or remained on their PI-based regimen. The study demonstrated that, after 48 weeks of treatment with Complera, 89% of switch patients had viral load less than 50 copies/mL, compared to 90% of patients who remained on a PI-regimen for 24 weeks. Complera was well tolerated in SPIRIT and there were few treatment discontinuations due to adverse events.

Marketed as Eviplera in the EU, the regimen also was recently granted European regulatory approval for any HIV-infected adult patients without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ≤ 100,000 HIV-1 RNA copies/mL.